(412 days)
The SoftLight Q-switched Nd: YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is designed to deliver a nominal output of 1.0 Joule per pulse at a fixed operating wavelength of 1064 nm in a collimated beam. The pulse repetition rate is 1, 2, 5 or 10 pulses per second (Hz) and single shot. The Q-Switched output pulses are nominally 6-20 nsec in duration. The output beam is delivered through a 7 mirror articulated arm and beam delivery handpiece which allows an easy access to the treatment site. The collimated laser beam gives a fixed spot size of between 6 and 7 mm at the treatment site. This laser can be set to deliver fluences of between approximately 1 to 3.5 J/cm2. The laser energy and repetition rate settings are adjusted and monitored through a microprocessor-controlled key pad on the control panel of the laser. The accessory topical lotion is a suspension of carbon powder, in a base of Light Mineral Oil, NF.
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use in combination with a ThermoLase-supplied topical lotion for laser skin resurfacing and for removing or lightening unwanted facial or body hair. The provided document focuses mainly on the device description and regulatory approval process, with limited details on specific acceptance criteria and a detailed study report. Based on the available information, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "Clinical trials involving human subjects followed for 8 months showed no safety issues." |
| Efficacy for Laser Skin Resurfacing | "The treatment was shown to remove or ablate skin epidermis in the treatment area." |
| Efficacy for Hair Removal/Lightening | (Not explicitly stated in terms of acceptance criteria or performance in the provided text, but is an indicated use. Substantial equivalence to a predicate device for this use is mentioned.) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical trials involving human subjects" but does not specify the exact sample size used for these trials.
The data provenance is clinical trials involving human subjects, implying prospective data collection. The country of origin is not explicitly stated, but the company (ThermoLase Corporation) is located in San Diego, California, suggesting the studies likely occurred in the USA or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Details regarding ground truth establishment, including the number and qualifications of experts (e.g., dermatologists, plastic surgeons), are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the document. The device is a laser system, not an AI diagnostic tool, so such a study would not be applicable in this context.
6. Standalone (Algorithm Only) Performance Study
This concept is not applicable as the device is a laser system, not a standalone algorithm. Its performance is intrinsically linked to the physical intervention of the laser and the topical lotion with human application.
7. The Type of Ground Truth Used
Based on the performance statements, the ground truth appears to be based on direct observation of clinical outcomes. For skin resurfacing, it's "removal or ablation of skin epidermis," which would likely be assessed visually or histologically by medical professionals. For safety, it's the absence of "safety issues."
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of laser device development, as it's not an AI/machine learning model in the modern sense. The "clinical trials involving human subjects" would serve as the primary data for demonstrating safety and efficacy, analogous to a validation set. The specific sample size for these trials is not provided.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" is not directly applicable. However, the ground truth for the clinical trials (the evidence demonstrating safety and efficacy) was established through clinical observation and assessment by medical professionals over an 8-month follow-up period. This would involve evaluations of skin changes (ablation/removal of epidermis) and the reporting/monitoring of adverse events.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.